Medical Ethics Corner: EpiPen 2.0

Recently there was a great deal of hoopla in the news when it was revealed that the manufacturer of the long time well known life-saving device, the EpiPen, had raised its price by five thousand percent since 2010. This was the lead story on nearly all the major and minor news outlets for about a week. Then, as is routinely the case with most news cycles, and certainly with a variety of abusive pharmaceutical pricing stories, the reports seemed to vanish. In the weeks that have ensued since the breaking story, Mylan, the drug giant behind he EpiPen, has done very little to rectify this seemingly outrageous rip-off of the American health care consumer. But now these poster-bad-boys of the industry are quietly taking things to an even more egregious level.

Last month the New York Times reported that Mylan is lobbying all involved parties, in particular the United States Preventive Task Force, to get EpiPen placed on the federal preventive list. By law, when a drug is positioned on this sacred list, most families would have very little or no out of pocket costs. Under the Affordable Care Act, recommendations from this task force must be adopted by all health insurance companies.

At first this sounds like a wonderful pro-consumer measure. Put EpiPen on the list, and no longer would co-pays and deductibles stand in the way of EpiPen access for allergy prone families. In fact this was the message in a peer reviewed article that appeared in the online edition of the American Journal of Medicine, the “official journal for the Alliance for Academic Internal Medicine.” While there certainly would be some life saving benefit up front for patients, let’s not ignore that the biggest winner here is the manufacturer. If EpiPen makes the list, Mylan would be able to continue charging as much as they want, or even higher, but without the patients complaining about the cost, the whole reason the news story broke in the first place. While patients would have no direct out of pocket costs, the bill for the EpiPen would then be paid by the federal government, health insurers and employers. Of course these costs in turn would eventually be passed on to unsuspecting patients through higher co-pays on other drugs, higher insurance premiums the next year, and higher taxes to fund the government programs that are legally required to pay for the EpiPen. Such a clever move by the folks at Mylan.

There are some major ethical issues here beyond the obvious, the outrageous (although perfectly legal) profits that Mylan is earning. UCLA professor Leonard Fromer MD who authored the journal article was a paid consultant for Mylan. He discloses this, in small print of course, with the article. Tonja Winders, chief executive of the Allergy and Asthma Network meanwhile has been busy lobbying key legislators in Washington, D.C. Her “consumer advocating” network has received, surprise, some hefty donations from Mylan as well. In an interview quoted in the Times article, Ms. Winder boldly states, “I’m being compensated to ensure access to epinephrine.” This is all public information and the flow of the monies are more or less transparent, but there sure seems to me to be just a bit of conflict of interest here.

In reality, getting EpiPen on the preventive list may be difficult. To date there are no prescription drugs for specific illnesses on the list. But Mylan has a long history of creative lobbying with an impressive track record when it comes to influencing government policies. The company pushed numerous federal and state laws that in some cases actually require schools, hotels, and restaurants to keep the EpiPen available on the premises. Mylan is currently putting the pressure on Congress to pass a law that would mandate EpiPens on all commercial airliners. And it can’t hurt that Mylan’s CEO, Heather Bresch, is the daughter of West Virginia U.S. Senator Joe Manchin.

As more of these stories become part of the public conscious I’m hopeful that the people of our country will demand some sort of pharmaceutical pricing reform. The fact that there are already congressional hearings underway on a variety of drug pricing issues gives me a glint of optimism but I’m afraid this will be a long drawn out process. I remember back to my organic chemistry college days when studying something about hydrogen molecules, we were taught, “the rich get richer.” It certainly rings true for the pharmaceutical industry and their organic molecules.